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NCT07170605 · ClinicalTrials.gov registry record · NA
The Building Resilience Program: Examining Self-Regulation, Behavior, and Resilience in Under-Resourced Preschoolers With ACEs
A NA study, sponsored by Cleveland State University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT07170605: Completed NA study, sponsored by Cleveland State University.
NCT07170605 is a NA study that has completed, run by Cleveland State University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07170605, a NA study, has completed, sponsored by Cleveland State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
\# Brief Summary The goal of this clinical trial is to learn if a occupational therapy-led trauma-informed care intervention can improve resilience, self-regulation, coping skills, and emotional health in preschoolers ages 2-4 years from under-resourced neighborhoods with a history of adverse childhood experiences (ACEs) and their caregivers. The main questions it aims to answer are: * Does the Building Resilience Program (BRP) improve stress management, self-regulation, positive affect, engagement, self-efficacy, coping skills and resilience in preschool children? * Does the Building Resilience Program (BRP) improve resilience, emotional management, and coping strategies in caregivers? Researchers will compare the Building Resilience Program group to a school readiness skills comparison group to see if the trauma-informed intervention produces greater improvements in resilience and related outcomes. Participants will: * Complete pre- and post-intervention assessments measuring resilience, coping skills, emotional health, occupational engagement, and quality of life * Attend 40-60 minute group sessions, 3x a week for 8 weeks (children will participate in either the BRP intervention or school readiness comparison group) * Complete individualized Goal Attainment Scaling to track personal progress (children) * Attend 2-3 in-person caregiver group sessions during the 8-week intervention period plus pre- and post-intervention meetings (caregivers) * Complete a program evaluation questionnaire at the end of the study (caregivers)
Primary Outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Curiosity and Persistence measures (parent proxy report, scores calculated as standardized scores for analysis). Original scoring for all is 1-5 scale (Never, Rarely, Sometimes, Often, Always). Higher scores (always/5) are considered higher and more characteristic of a child with characteristics of being resilient.
Interventions
- BEHAVIORAL Mental health, positive coping strategies promoting self-regulation and adaptive skills
- OTHER Standard care/School Readiness Condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
What the finished NCT07170605 record still lists
NCT07170605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Mental health, positive coping strategies promoting self-regulation and adaptive skills is the first listed.
NCT07170605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07170605 about?
NCT07170605 is a clinical study titled "The Building Resilience Program: Examining Self-Regulation, Behavior, and Resilience in Under-Resourced Preschoolers With ACEs". \# Brief Summary The goal of this clinical trial is to learn if a occupational therapy-led trauma-informed care intervention can improve resilience, self-regulation, coping skills, and emotional health in preschoolers ages 2-4 years from under-resourced neighborhoods with a history of adverse child...
What is the current status of trial NCT07170605?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2023-10-01. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT07170605?
The interventions under investigation include: Mental health, positive coping strategies promoting self-regulation and adaptive skills (BEHAVIORAL), Standard care/School Readiness Condition (OTHER).
Who is sponsoring clinical trial NCT07170605?
This trial is sponsored by Cleveland State University, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07170605's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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